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BioWorld - Thursday, April 16, 2026
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Financings for Dec. 6, 2024

Dec. 6, 2024
Biopharmas raising money in public or private financings, including: Cambium, Janux, NLS, Nuvig, Oncoinvent, Quantum.
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Illustration of proteins on neurons in the aging brain

Ketone bodies could clear misfolded proteins in the brain

Dec. 6, 2024
A ketone body, a molecule derived from the metabolism of acids to obtain energy when glucose is not available, could become an effective ally in treating Alzheimer’s or preventing the effects of aging on the brain. A group of scientists at the Buck Institute for Research on Aging have studied the role of β-hydroxybutyrate as a signaling metabolite of misfolded proteins by interacting with them and altering their solubility, a mechanism that allows their elimination, as observed in preclinical models.
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Illustration of dividing breast cancer cell

Estrous cycle alters murine breast cancer response to chemotherapy

Dec. 5, 2024
By Mar de Miguel
In breast cancer, neoadjuvant chemotherapy reduces the tumor before surgery. However, the response to this treatment does not depend solely on the subtype of malignancies. Other factors could play a key role in its effectiveness, as shown in a study that described how the estrous cycle phases contribute to this variation. The researchers propose adjusting the approach to the most suitable moment for patients.
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FDA approval seal on blue glittering background

First for Merus, first for NRG1+ cancers: US FDA approves Bizengri

Dec. 5, 2024
By Karen Carey
Merus NV gained accelerated U.S. FDA approval of Bizengri (zenocutuzumab) as the first and only targeted therapy indicated for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease. The approval came about seven months after the FDA accepted the BLA for filing under priority review, and two months ahead of the PDUFA goal date of Feb. 4, 2025, which had been extended by three months in November as the agency reviewed CMC information submitted in response to its request.
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US FDA considers flexing new accelerated approval authorities

Dec. 5, 2024
By Mari Serebrov
Seeking accelerated approval as a fallback when clinical evidence is not quite strong enough for traditional approval appears destined for the dustbins of history.
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Art concept for bladder

Protara, CG climb bladder ladder with SUO cancer findings

Dec. 5, 2024
By Randy Osborne
Among the drug developers with clinical results featured at the annual meeting of the Society for Urologic Oncology (SUO) in Dallas were Protara Therapeutics Inc. with phase II numbers and CG Oncology Inc. with a phase III update. Protara’s shares (NASDAQ:TARA) closed Dec. 5 at $6.02, up $2.48, or 70%, having traded as high as $10.48 during the day. Less reactive was stock in CG (NASDAQ:CGON), which ended at $33.56, down $2.35.
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Sanbexin sublingual tablets

NMPA clears drugs from Innovent/Hutchmed, Hengrui, Henlius, Luye

Dec. 5, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
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Regulatory actions for Dec. 5, 2024

Dec. 5, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allay, Biocardia, Biopharmaceutical Research, Leo, Outlook, Simcere, Stoke.
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Other news to note for Dec. 5, 2024

Dec. 5, 2024
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dewpoint, Eli Lilly, GSK, Ionis, Martin, Mitsubishi, Rgenta, Rgenta, Theratechnologies, Vincerx.
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In the clinic for Dec. 5, 2024

Dec. 5, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Atea, Can-Fite, Eli Lilly, Everest Medicines, Evommune, Impact Biotech, Neurosense Therapeutics, Relmada Therapeutics, Scitech Development, TC Biopharm, Teva Pharmaceutical. Thermosome, Trevi, Vivavision.
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